Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
AEGIS-CKD
A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
1 other identifier
interventional
167
1 country
27
Brief Summary
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2016
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2018
CompletedResults Posted
Study results publicly available
May 1, 2020
CompletedNovember 2, 2020
October 1, 2020
1.1 years
August 30, 2016
November 19, 2019
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hb Concentration From Baseline to Week 16
Change in hemoglobin concentration from baseline to Week 16.
16 weeks
Secondary Outcomes (11)
Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16
16 weeks
Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
16 weeks
Change in Hb Concentration From Baseline to Week 8
8 weeks
Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
16 weeks
Changes in Ferritin From Baseline to Week 16
baseline to week 16
- +6 more secondary outcomes
Study Arms (2)
Oral ferric maltol
EXPERIMENTAL30mg capsules BID
Oral placebo
PLACEBO COMPARATORMatching placebo capsules BID
Interventions
Eligibility Criteria
You may qualify if:
- Ability to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form. Must sign and date the informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure.
- Willing and able to comply with study requirements.
- Age ≥ 18 years at the time of informed consent.
- A current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2 and ≥15 mL/min/1.73m2, as calculated using the abbreviated version of the Modified Diet in Renal Disease equation (MDRD) assessed via screening laboratory results.
- Iron deficiency anemia defined by the following criteria assessed via screening laboratory results:
- Hb \<11.0g/dL and ≥8.0g/dL
- AND ferritin \<250ng/mL with a Transferrin saturation (TSAT) \<25% OR ferritin \<500ng/mL with a TSAT of \<15%
- Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive medications. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.
You may not qualify if:
- Anemia due to any cause other than iron deficiency, including, but not limited to:
- Untreated or untreatable severe malabsorption syndrome.
- Myelosuppression use (permitted if taken at a stable dose and frequency for at least 12 weeks prior to randomization and are expected to stay stable throughout the double-blind treatment period so long as there is no clinical evidence of the myelosuppression contributing to the subject's anemia).
- Administration with any of the following prior to randomization:
- IV iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within the previous 12 weeks.
- Single agent oral iron supplementation, taken specifically to treat anemia (e.g. ferrous sulfate, fumarate and gluconate) within the previous 2 weeks. Multivitamins are permitted.
- Use if ferric citrate and sucroferric oxyhydroxide within the previous 1 week.
- ESAs within the previous 4 weeks
- Blood transfusion or donation within the previous 12 weeks.
- Dimercaprol or cloramphenicol within the previous 7 days.
- Current use of methyldopa.
- Currently receiving dialysis or initiation of dialysis is considered likely during the study.
- Renal transplant within 12 months prior to randomization or is considered likely during the study.
- Known hypersensitivity or allergy to the active substance or excipients of ferric maltol or placebo capsules.
- Contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anemia, thalassemia, or lead intoxication induced anemia.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Peoria, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Prescott, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Coral Springs, Florida, United States
Unknown Facility
Edgewater, Florida, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Pontiac, Michigan, United States
Unknown Facility
Roseville, Michigan, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Bethlehem, Pennsylvania, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Hampton, Virginia, United States
Related Publications (1)
Pergola PE, Kopyt NP. Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. Am J Kidney Dis. 2021 Dec;78(6):846-856.e1. doi: 10.1053/j.ajkd.2021.03.020. Epub 2021 May 23.
PMID: 34029682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jackie Mitchell MA DPhil
- Organization
- Shield Therapeutics
Study Officials
- STUDY DIRECTOR
Mark Sampson, MBChB
Shield Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
November 18, 2016
Study Start
December 1, 2016
Primary Completion
January 18, 2018
Study Completion
October 10, 2018
Last Updated
November 2, 2020
Results First Posted
May 1, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share